Phase 1
N=14
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01177293 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] — 401.655; 360.619 hr*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Amlodipine - reference (Drug); Amlodipine ODT - test (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
401.655; 360.619 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
331.300; 330.394 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
6.427; 5.571 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
8.00; 10.00 | — |
| SECONDARY Plasma Decay Half-life (t1/2) |
51.374; 45.120 | — |
Summary
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
Data sourced from ClinicalTrials.gov (NCT01177293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.